AstraZeneca

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Enhertu, a HER2-directed antibody drug conjugate (ADC), has demonstrated significant progress in treating HER2-low and HER2-ultralow metastatic breast cancer following one or more lines of endocrine therapy. The high-level results from the DESTINY-Breast06 Phase … Read the full press release →

(IN BRIEF) AstraZeneca’s Truqap, in combination with Faslodex, has received a positive recommendation from the European Medicines Agency (EMA) for treating estrogen receptor-positive, HER2‑negative locally advanced or metastatic breast cancer with specific genetic alterations. The recommendation follows promising results from … Read the full press release →

(IN BRIEF) AstraZeneca’s IMPACT CKD model predicts a significant increase in chronic kidney disease (CKD) across eight countries, with up to 16.5% of the population affected by 2032, including a substantial rise in advanced-stage cases. Presented at the 2024 ISN … Read the full press release →

(IN BRIEF) AstraZeneca announces positive outcomes from the ADRIATIC Phase III trial, revealing that its immunotherapy drug Imfinzi (durvalumab) demonstrated a significant improvement in overall survival (OS) and progression-free survival (PFS) among patients with limited-stage small cell lung cancer (LS-SCLC) … Read the full press release →

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been acknowledged by the US FDA for treating adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative breast cancer who have received prior systemic … Read the full press release →

(IN BRIEF) AstraZeneca and Sanofi celebrate the approval of Beyfortus (nirsevimab) in Japan by the Ministry of Health, Labour, and Welfare for preventing lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in neonates, infants, and children entering … Read the full press release →

(IN BRIEF) AstraZeneca announces the approval of Truqap (capivasertib) in combination with Faslodex (fulvestrant) by the Japanese Ministry of Health, Labour, and Welfare (MHLW) for treating adult patients with unresectable or recurrent hormone receptor-positive, HER2-negative breast cancer. The approval, based … Read the full press release →

(IN BRIEF) Ultomiris (ravulizumab-cwvz) has gained approval from the FDA as the inaugural long-acting C5 complement inhibitor for treating adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD). The approval, based on the CHAMPION-NMOSD Phase III trial’s … Read the full press release →

(IN BRIEF) EQT Life Sciences announces the acquisition of its portfolio company, Amolyt Pharma, by Alexion, AstraZeneca Rare Diseases, for a total deal value of $1.05 billion. This acquisition underscores Amolyt’s significant advancements in developing novel treatments for rare endocrine … Read the full press release →

(IN BRIEF) The Conference Forum announced the launch of the 8th annual Patients as Partners® Europe meeting, scheduled for May 14-15, 2024, at Plaisterers’ Hall in London, England. This event brings together pharma R&D and patient advocacy to discuss patient … Read the full press release →

(IN BRIEF) In early 2024, Europe’s medical and research communities announced major breakthroughs in cancer care, highlighting new treatments like AstraZeneca and Daiichi Sankyo’s datopotamab deruxtecan for lung and breast cancer, and AstraZeneca’s Tagrisso for EGFR-mutated lung cancer. Diagnostic advancements … Read the full press release →

(IN BRIEF) The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for datopotamab deruxtecan (Dato-DXd), developed by AstraZeneca and Daiichi Sankyo, for the treatment of nonsquamous non-small cell lung cancer (NSCLC) and hormone receptor (HR)-positive, HER2-negative breast … Read the full press release →

(IN BRIEF) Voydeya (danicopan), a first-in-class oral Factor D inhibitor, has been recommended for marketing authorization in the European Union (EU) as an add-on to ravulizumab or eculizumab for adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who experience residual haemolytic … Read the full press release →

(IN BRIEF) AstraZeneca and Daiichi Sankyo’s Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted by the FDA for the treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) in patients who have undergone prior … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso (osimertinib) demonstrates significant improvement in progression-free survival (PFS) for patients with unresectable, Stage III EGFR-mutated non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) in the LAURA Phase III trial. The trial, led by Dr. Suresh Ramalingam, … Read the full press release →

(IN BRIEF) AstraZeneca’s Tagrisso receives FDA approval for treating adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) following a Priority Review. The decision is based on FLAURA2 Phase III trial results demonstrating that Tagrisso plus … Read the full press release →

(IN BRIEF) In a Phase III trial conducted in Japan, acoramidis, an investigational treatment for transthyretin-mediated amyloid cardiomyopathy (ATTR-CM), demonstrated promising high-level results consistent with the global BridgeBio Pharma, Inc. ATTRibute-CM Phase III trial. The trial in Japan aimed to … Read the full press release →

(IN BRIEF) The Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Voydeya (danicopan), a groundbreaking oral Factor D inhibitor, for the treatment of paroxysmal nocturnal haemoglobinuria (PNH). Voydeya is indicated in Japan for use in combination … Read the full press release →

(IN BRIEF) AstraZeneca has announced its definitive agreement to acquire Gracell Biotechnologies Inc. (NASDAQ: GRCL), a global biopharmaceutical company specializing in cell therapies for cancer and autoimmune diseases. This strategic move aims to bolster AstraZeneca’s presence in the field of … Read the full press release →

(IN BRIEF) AstraZeneca is set to unveil promising data at the 65th American Society of Hematology (ASH) Annual Meeting, highlighting its expanding hematology pipeline and the enduring effectiveness of Calquence in treating chronic lymphocytic leukemia (CLL). The presentation includes six-year … Read the full press release →